Active Ingredient
Lidocane hydrochloride, 4%
Nothing
FDA Label NDC 70411-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H2ocean, Llc for the product Nothing (NDC 70411-102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - when using, otc - do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain reliever
Uses
For the temporary relief of pain and/or itching associated with minor skin irritations
Warnings
For external use only
Otc - When Using
When using this product avoid contact with the eyes. In case of eye contact, flush eyes with water.
Otc - Do Not Use
Do not use in large quantities, particularly on raw surfaces of blistered areas.
Otc - Stop Use
If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.
Directions
Adults and children 2 years of age and older: Apply 1-2 pumps of the foam soap to the affected area 3-4 times daily.
Children under 2 years of age: consult a doctor.
For best results, do not use with alcohol based products.
Inactive Ingredients
Purified water, Poloxamer, Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Disodium ETDA, Sea Salt
Other
Questions? 1-888-420-2326
H2Ocean (r)
First In First Aid (TM)
H2Ocean's Nothing is the choice for first aid when ou want to feel NOTHING.
H2Ocean, LLC, Stuart, FL, USA
H2Ocean Europe SRL LTD., Waterford, Ireland
USA / EU +1 772.219.8183
Made in USA
www.H2Ocean.com
Package Label.Principal Display Panel
H2Ocean(r)
First In First Aid (TM)
NOTHING (TM)
Pain Relieving Soap with Lidocaine
Anesthetic
1.7 Fl. Oz. (50 ml.)
* Please review the disclaimer below.
